Company* (Country; Symbol)

Product

Description

Indication

Status (Date)


AUTOIMMUNE

Amgen Inc. (AMGN) and Wyeth

Enbrel (FDA-approved)

Etanercept; anti-TNF-alpha antibody

All approved indications

FDA approved once-weekly dosing of Enbrel across all indications (10/20)

Genentech Inc. (NYSE:DNA) and XOMA Ltd. (XOMA)

Raptiva

Efalizumab; humanized antibody designed to block T cells implicated in psoriasis

Chronic moderate to severe plaque psoriasis in adults

FDA approved Raptiva, a biologic injected once a week; XOMA will get about 25% of U.S. sales, which are expected to start by the end of November (10/27)

CANCER

Allos Therapeutics Inc. (ALTH)

RSR13

Efaproxiral; radiation sensitizer

Metastatic breast cancer

Allos submitted to the FDA the second of three data components for its new drug application (10/2)

Aton Pharma Inc.*

SAHA

Histone deacetylase inhibitor

Multiple myeloma

FDA granted orphan designation to the product (10/13)

ILEX Oncology Inc. (ILXO)

Clofarabine

Second-generation purine nucleoside antimetabolite

Refractory or relapsed acute pediatric leukemia

ILEX submitted the first part of a rolling new drug application, and intends to complete the NDA filing in the first half of 2004 (10/22)

ImClone Systems Inc. (IMCL) and Bristol-Myers Squibb Co.

Erbitux

Cetuximab; antibody designed to block EGFR

Metastatic colorectal cancer

FDA accepted for filing and review the BLA for Erbitux in combination with irinotecan for EGFR-expressing disease (10/10)

NeoRx Corp. (NERX)

Skeletal targeted radiotherapy

Targeted therapeutic consisting of small molecule and radionuclide

Multiple myeloma

NeoRx reached agreement with FDA on special protocol assessment for design of Phase III trial; it also said one trial would be sufficient for registration (10/1)

Sonus Pharmaceuticals Inc. (SNUS)

Tocosol paclitaxel

Re-formulation of the cancer drug

Bladder cancer

The FDA granted fast-track status to the product in treating inoperable transitional cell carcinoma of the urothelium (10/29)

Tularik Inc. (TLRK)

T67

Small molecule that binds to beta-tubulin

Unresectable hepatocellular carcinoma

The FDA granted fast-track status to the drug in first-line therapy; the drug is being tested in a pivotal study (10/22)

CARDIOVASCULAR

Biopure Corp. (BPUR)

Hemopure

Hemoglobin glutamer - 250 (bovine)

Anemia in orthopedic surgeries and reduction of blood cell tranfusions

FDA had questions about the BLA for Hemopure; Biopure said collecting the data will take several months to complete (10/30)

CV Therapeutics Inc. (CVTX)

Ranexa

Ranolazine; partial inhibitor of fatty-acid oxidation

Chronic angina

FDA's Cardiovascular and Renal Drugs Advisory Committee will review Ranexa at its Dec. 9 meet- ing (10/23); FDA issued approvable letter indicating additional clinical information would be needed before gaining approval (10/30)

CENTRAL NERVOUS SYSTEM

Alkermes Inc. (ALKS) and Johnson & Johnson

Risperdal Consta

Risperidone formulated in Alkermes' long-acting Medisorb technology

Schizophrenia

Risperdal Consta, which has been approved in more than 40 countries, was approved and will be sold in the U.S. by J&J unit Janssen Pharmaceutica Products LC (10/29)

Avigen Inc. (AVGN)

AV201

Gene therapy that delivers the gene for AADC to help regulate dopamine levels

Parkinson's disease

The Recombinant DNA Advisory Committee recommended that Avigen could begin clinical testing of the product (10/20)

Cephalon Inc. (CEPH)

Provigil (FDA-approved)

Modafinil

Improving wakefulness

The FDA issued an approvable letter to broaden the label to include shift workers and those with obstructive sleep apnea/hypopnea syndrome; launch is expected in 1Q:04 (10/21)

DOV Pharmaceuticals Inc. (DOVP)

Ocinaplon

Modulates subset of GABA-A receptors

Anxiety

FDA placed hold on start of Phase III trial until more safety data are provided (10/2)

Endo Pharmaceuticals Inc. (subsidiary of Endo Pharmaceuticals Holdings Inc.; ENDP)

Oxymorphone

Extended- and immediate-release formulations of oxymorphone

Pain

FDA issued approvable letters for both products calling on company to provide additional information and conduct additional trials (10/20)

Neurobiological Technologies Inc. (NTII) and Forest Laboratories Inc.

Namenda

Memantine; NMDA receptor antagonist

Moderate to severe Alzheimer's disease

FDA approved the drug, which is expected to be available in January (10/17)

Pozen Inc. (POZN)

MT 100

Tablet formulation

Migraine

Pozen said FDA accepted the NDA for filing; action is expected by June 2004 (10/7)

Pozen Inc. (POZN) and Xcel Pharmaceuticals Inc. *

MT 300

Formulation of dihydroergotamine mesylate

Migraine

The FDA issued a non-approvable letter based on failure to achieve statistical significance on secondary endpoints at two hours 10/20)

INFECTION

Tanox Inc. (TNOX)

TNX-355

Humanized monoclonal CD4 molecule

HIV

FDA granted fast-track status in HIV patients who have failed or are failing antiretroviral therapy (10/9)

Vertex Pharmaceuticals Inc. (VRTX) and GlaxoSmithKline plc (UK)

Lexiva

Fosamprenavir calcium; protease inhibitor

HIV infection

The FDA approved Lexiva for the treatment of HIV infection in adults in combination with other antiretroviral drugs (10/21)

MISCELLANEOUS

ISTA Pharmaceuticals Inc. (ISTA)

Vitrase

Ovine hyaluronidase

Agent to facilitate absorption of other drugs

ISTA said the FDA accepted for filing and review an NDA for the drug (10/7)

Savient Pharmaceuticals Inc. (SVNT)

--

Sodium hyaluronate product

Pain associated with osteoarthritis of the knee

FDA issued approvable letter sub- ject to manufacturing inspection and labeling (10/8)


Notes:

* Privately held

Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market.

NYSE = New York Stock Exchange.

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